NCT01807754

Simulated Screening Study for Breast Imaging

Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: Female
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, simulated breast cancer screening study. The goal of the study is to explore these scanning modalities: 1\) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS) 2\. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone.

Detailed description

This is a pilot, simulated breast cancer screening study. In a population enriched with mammographic call-backs, we will study whether: 1\) Combined digital breast tomosynthesis(DBT)/dual-sides 3 dimensional-automated ultrasound(AUS)will result in a lower call-back rate than digital breast tomosynthesis(DBT)alone. 2\. Explore the utility of photoacoustic imaging as an adjunct to digital breast tomosynthesis(DBT)/ultrasound(US)alone. This study will compare two new breast imaging systems to digital mammography and hand-held ultrasound that are commonly used to find and evaluate breast masses. Images will be done with digital breast tomosynthesis (DBT) and 3-D automated ultrasound(AUS) which will be done in the breast imaging clinic of the main hospital followed by the second light and ultrasound imaging that will be completed in the research lab.

Conditions

• Breast Cysts
• Breast Tumors

Interventions

Type	Name	Description
PROCEDURE	X-ray and ultrasound imaging scanning	Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging.
PROCEDURE	Photoacoustic imaging scans for breast cancer screening	The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast.

Timeline

• Start date: 2012-12-01
• Primary completion: 2020-04-23
• Completion: 2020-04-23
• First posted: 2013-03-08
• Last updated: 2020-05-21

Locations

1 site across 1 country: United States